White Paper

Addressing Unique Production Problems In Cell and Gene Therapy With Manufacturing Execution System (MES)

Personalized medicine is fast becoming a reality for many conditions. Even in patients with the same disease, generic medicines will commonly help some patients, have minimal effect on some and potentially adverse effects on others. Based on our improved understanding of genetics, the immune system and stem cells, new personalized cell and gene therapy treatments are being manufactured for individual patients. A unique difference is that traditional pharmaceutical manufacturing is ‘make to stock’ but cell and gene therapy manufacturing is ‘make to order’ – each ‘order’ is different and patient specific. In addition for each patient the manufacturing starts with uniquely different material.

T cells gives our immune systems the capacity to protect against the vast array of bacteria, viruses and fungi that we encounter. As the role of T cells in controlling cancers was recognized, they have begun to be exploited therapeutically. These therapies initiate a bioengineered immune system attack on a patient’s cancer cells using modified versions of the patient’s own cells.

But how do you manufacture such a therapy? To deliver cell and gene therapy treatments at scale bio-pharmaceutical companies are moving away from complex paper based documentation, integrating many different electronic systems, and automating previously manual verification processes between collection, logistics, manufacturing and treatment centers.